Measuring devices that are conventionally used in the field of clinical testing are mainly large-scale automated devices and POCT (Point of Care Testing) devices.
The large-scale automated devices are provided at a central clinical-testing department of hospitals and at companies that mainly undertake clinical testings, and by using these devices, a sample of many patients can be tested for a plurality of items (for example, Patent Publication Document 1). For example, a large automated device manufactured by Hitachi, Ltd., type 7170, is capable of completing 800 tests/hour on 36 items at maximum. Therefore, the large-scale automated device has been contributing to efficiency in testing, which makes it suitable for hospitals with a large number of examinee.
On the other hand, POCT devices are used for clinical testing conducted in medical field other than a testing room and a testing center of hospitals, and include devices used in at-home medical care (for example, Patent Publication Document 2 and Patent Publication Document 3). For example, a blood-sugar sensor, a pregnancy test reagent, an ovulation test reagent, and an HbAlc and microalbumin testing device (for example, DCA2000 manufactured by Bayer AG) may be mentioned. These POCT devices are less applicable for all-purpose use compared with large-scale automated devices, but capable of easy and quick measurement by focusing on a marker substance unique to a disease. Thus, the devices are effective for screening and monitoring examinees. Additionally, the POCT devices are small and portable, can be introduced for low costs, and further usable for anyone without particular specialties in terms of operation.
There are many measuring items currently for clinical test. When a body fluid such as urine is used as a sample, the measurement methods are roughly divided to an optical measurement method and an electrochemical measurement method, mainly. In the large-scale automated devices and the POCT devices, measurement is conducted by using the optical measurement method or electrochemical measurement method.
Recently, a rise in medical expense and an increase in lifestyle-related disease patient have been causing a strain on medical economy, and a reduction in medical expense and avoidance on increase in lifestyle-related disease patient have been problems. As a fundamental solution for such problems, Evidence Based-Medical (EBM) has been considered. By conducting EBM, medical care can be managed objectively for a respective patient. Then, by practicing preventive medical care based on EBM, a control on the number of the lifestyle-related disease patient particularly is particularly expected.
For establishing and practicing the EBM, test information from clinical tests is essential information. Test information in EBM includes test results and solutions for patient based on the results. The solutions for patients refer to instructions on daily habit such as meal management and treatment by medication. That is, the testing in the EBM can be evaluated as “task-setting” and “policy-determining” for those who are to receive medical care. Therefore, in EBM, to provide safe and substantial solution with further feeling of security, it is necessary to clearly present the problem for those who are to receive medical care. Thus, in clinical testing, it is important to know each of the test result easily and quickly on a plurality of interrelated test items.
Conventional large-scale automated device as in the above are applicable for all-purpose, and many items can be tested regardless of presence or absence of relevance to the disease. However, the complicated structure of the device makes the operation difficult for those without expertise, and further, there are problems in that it takes long to obtain test results, and involves a longer time for giving the feedback of the results to the examinee. Additionally, although the above POCT device is excellently operable and is capable of easy and quick test, it is a measuring device specially for a marker related to a specific disease, and is not capable of testing a plurality of items.
Thus, there has been proposed a device comprising a cavity to which a sample liquid flows in by capillary effects; being used for biochemical or clinical examination; and having an electrode structure for measuring the sample's electrochemical characteristics, and a reagent such as antibody and enzyme capable of being released in the cavity; wherein a wall of the cavity is transparent so that the inner cavity can be optically measured (for example, Patent Publication Document 4).
[Patent Publication Document 1] JP 09-127126 A
[Patent Publication Document 2] JP 07-248310 A
[Patent Publication Document 3] JP 03-046566 A
[Patent Publication Document 4] U.S. Pat. No. 5,141,868B